Products (Amendment) Regulations, 2023

L.N. 229 of 2023

TOBACCO (SMOKING CONTROL) ACT

(CAP. 315)

Manufacture, Presentation and Sale of Tobacco and Related

Products (Amendment) Regulations, 2023

IN EXERCISE of the powers conferred by article 9 o f the

Tobacco (Smoking Control) Act, the Minister responsible for public

health has made the following regulations:-

(1) The title of these regulations is the Manufacture, Citation,

Presentation and Sale of Tobacco and Related Products (Amendment) commencement

and scope.

Regulations, 2023 and these regulations shall be read and construed as

one with the Manufacture, Presentation and Sale of Tobacco and S.L. 315.10.

Related Products Regulations, hereinafter referred to as "the principal

regulations".

(2) These regulations shall come into force on the 23rd

October 2023.

(3) The scope of these regulations is to transpose Commission

Delegated Directive (EU) 2022/2100 of 29 June 2022 amending

Directive 2014/40/EU of the European Parliament and of the Council

as regards the withdrawal of certain exemptions in respect of heated

tobacco products and to carry out other necessary amendments.

In sub-regulation (2) of regulation 1 of the principal Amends

regulations immediately after the words "and repealing Directive regulation

the principal

2001/37/EC", there shall be added the words ", as may be amended, regulations.

from time to time".

Sub-regulation (7) of regulation 7 of the principal Amends

regulations shall be substituted by the following new sub-regulation: regulation

the principal

regulations.

"(7) Tobacco products other than cigarettes, roll-your-own

tobacco and heated tobacco products shall be exempted from the

prohibitions laid down in sub-regulations (1) and (4)

Provided that for the purposes of this sub-regulation

"heated tobacco product" shall mean a novel tobacco product

that is heated to produce an emission containing nicotine and

other chemicals, which is then inhaled by users and that,

depending on its characteristics, is a smokeless tobacco product

or a tobacco product for smoking

Provided further that the provision of this sub-

regulation shall in no way prejudice or reduce the applicability of

the ban stipulated in regulation 21.".

Paragraph (a) of sub-regulation (4) of regulation 9 of the

principal regulations shall be substituted by the following new

paragraph

"(a) printed on a white background in Black Helvetica

bold type, in a font size which ensures that the text occupies the

greatest possible proportion of the surface area reserved for it;".

Regulation 11 of the principal regulations shall be amended

as follows

(a) the marginal note thereof shall be substituted by the

following new marginal note

"Labelling of tobacco products for smoking other

than cigarettes, roll-your-own tobacco, waterpipe tobacco

and heated tobacco products.";

(b) the first paragraph of sub-regulation (1) thereof shall

be substituted by the following new sub-regulation

"11. (1) (a) Tobacco products for smoking other

than cigarettes, roll-your-own tobacco, waterpipe tobacco

and heated tobacco products are exempt from the

obligations to carry the information message laid down in

regulation 9(2) and the combined health warnings laid

down in regulation 10. In addition to the general warning

provided for in regulation 9(1), each unit packet and any

outside packaging of such products shall carry one of the

text warnings listed in Schedule 2. The general warning

specified in regulation 9(1) shall include a reference to the

cessation from smoking services referred to in regulation

10(1)(b);

(b) the general warning shall appear on the most

visible surface of the unit packet and any outside

packaging;

(c) each text warning listed in Schedule 2 shall be

displayed to the extent possible in equal numbers on each

brand of these products. The text warnings shall appear on

the next most visible surface of the unit packet and any

outside packaging;

(d) for unit packets with a hinged lid, the next most

visible surface is the one that becomes visible when the

packet is open;

(e) for the purposes of this sub-regulation "heated

tobacco product" means a novel tobacco product that is

heated to produce an emission containing nicotine and

other chemical substances, which is then inhaled by users

and that, depending on its characteristics, is a smokeless

tobacco product or a tobacco product for smoking

Provided that the provision of this sub-

regulation shall in no way prejudice or reduce the

applicability of the ban stipulated in regulation 21.".

Regulation 16 of the principal regulations shall be Susbstitutes

regulation 16 of

substituted by the following new regulation

the principal

regulations.

"16. (1) Cross-border distance sales of tobacco

products to consumers located in Malta shall be

prohibited.

(2) Retail outlets located in Malta engaging in

cross-border distance sales of tobacco products shall

not supply such products to consumers in Member

States where such sales have been prohibited. Retail

outlets located in Malta intending to engage in cross-

border distance sales to consumers located in the Union

shall register with the Superintendent and with the

competent authorities in the Member State where the

actual or potential consumers are located. All retail

outlets located in Malta intending to engage in cross-

border distance sales shall submit the following

information to the Superintendent when registering

(a) name or corporate name and

permanent address of the place of activity from

where the tobacco products shall be supplied;

(b) the starting date of the activity of

offering tobacco products for cross-border

distance sales to consumers by means of

information society services;

(c) the address of the websites used for

that purpose and all relevant information

necessary to identify the website.

(3) The Superintendent shall make publicly

available the list of all retail outlets located in Malta

and engaging in cross-border distance sales that are

registered in accordance with this regulation. Retail

outlets may only start engaging in cross-border distance

sales when they have received confirmation of their

registration with the Superintendent.

(4) Retail outlets located in Malta supplying

tobacco products sold by cross-border distance sales

shall nominate to the Superintendent, a natural person

who shall be responsible for verifying, before the

tobacco products reach the consumer, that they comply

with the national provisions of the Member State where

the consumer is located at the time that the consumer

orders the product.

(5) Retail outlets located in Malta engaging in

cross-border distance sales shall operate an age

verification system, which verifies, at the time of sale,

that the purchasing consumer complies with minimum

age requirements provided for under the national

provisions of the Member State where the consumer is

located at the time that the consumer orders the product.

The retail outlet or natural person nominated pursuant

to sub-regulation (4) shall provide to the

Superintendent a description of the details of the age

verification system and how it functions.

(6) Retail outlets located in Malta shall only

process personal data of the consumer in accordance

with Regulation (EU) 2016/679 of the European

Parliament and of the Council of 27 April 2016 and that

data shall not be disclosed to the manufacturer of

tobacco products or companies forming part of the

same group of companies or to other third parties.

Personal data shall not be used or transferred for

purposes other than the actual purchase. This also

applies if the retail outlet forms part of a manufacturer

of tobacco products.".

Regulation 18 of the principal regulations shall be amended

(a)

sub-regulation (4) thereof shall be amended as

follows

(i) paragraph (a) thereof shall be substituted by the

following new paragraph

"(a) unit packets of electronic cigarettes and

refill containers shall include a leaflet with

information in the Maltese or in the English language

on

(i) instructions for use and storage of

the product, including a reference that the

product is not recommended for use by young

people and non-smokers;

(ii)

contra-indications;

(iii) warnings for specific risk groups;

(iv) possible adverse effects;

(v)

addictiveness and toxicity; and

(vi) contact details of the manufacturer

or importer and a legal or natural contact person

within the Union

Provided that the leaflet containing

the information stipulated in this paragraph may

be substituted by a label affixed to the

packaging or a leaflet contained within the

packaging, which includes a Quick Response

(QR) code containing an electronic link with

information stipulated in this paragraph in

either the Maltese or the English language.".

(ii) paragraph (c) thereof shall be substituted by the

following new paragraph

"(c) the health warning shall comply with the

requirements specified in regulation 9(4). The text of

the health warnings shall be parallel to the main text

on the surface reserved for these warnings. In

addition, it shall

(i) appear on the two largest surfaces of

the unit packet and any outside packaging;

(ii) cover 32% of the surfaces of the

unit packet and any outside packaging.".

(b) in sub-regulation 6 thereof, immediately after the

words "cigarettes and refill containers." there shall be added the

words "For the purpose of this sub-regulation, the terms

"electronic cigarettes" and "refill containers" shall refer to both

nicotine and non-nicotine containing electronic cigarettes and

refill containers.";

(c) in paragraph (d) of the sub-regulation (7) thereof the

words "an English translation thereof." shall be substituted by

the words "an English translation thereof:" and immediately

thereafter there shall be added the following new proviso

"Provided that the Superintendent shall monitor the market

developments concerning electronic cigarettes and refill containers,

including any evidence that their use is a gateway to nicotine addiction

and ultimately traditional tobacco consumption among young people

and non-smokers.".

Immediately after sub-regulation (4) of regulation 19 of the

principal regulations, there shall be added the following new sub-

regulation

"(5) Regulation 16 shall also apply to cross-border

distance sales of herbal products for smoking.".

€0.54